Role Summary
This role sits within the Production team at Autolus where there is a shared mission of manufacturing and delivering Autologous products to our patients. Please note that this is a shift based role working across Sunday to Wednesday / Wednesday to Saturday. (Bi-weekly shift rotation between early - 6AM - 345PM and lates 1215PM -10PM.
This is a shift base role within a dynamic, bright, enthusiastic and evolving team.
The role will be based on site, within the Autolus Manufacturing site(s) in Stevenage, however, may occasionally involve travel to other sites.
Must meet the requirements of working in a cleanroom/ aseptic environment
Key Responsibilities
To demonstrate initiative & work as a flexible & motivated team member
To follow all SOPs/SWI applicable & in which the individual has been trained
To act at all times in compliance with GMP & to proactively raise any issues
To act in a safe manner at all times (in compliance with the Health & Safety at work act & all other relevant legislation) & to use the appropriate reporting systems to highlight potential hazards
To stay up to date with all training requirements as identified in the job holders training plan
To participate in continuous improvement (CI), root cause analysis (RCA) & corrective & preventative (CAPA) activities within span of influence
Role-specific - Make (~65%)
Additional core technical competencies;
Cell processor set up for cell culture activities
Cell culture sampling, counting, washing, activation, feeding & harvesting
Cell culture Magnetic Enrichment & Depletion (MACS)
Drug Product Visual inspection
Process adjustments
Labelling
Reconciliation
To execute non-standard &/or first-time product manufacture under supervision of Product Development / MSAT staff